Kornimate/medical-research-clean huggingface dataset:
cinpt in autologous diep flap breast reconstruction

Conditions: Breast Cancer; Wound Dehiscence, Surgical

Summary: in women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (diep) flap is a common surgical procedure that aims to restore both the appearance and texture of the breast(s).specifically, this requires the transfer of skin, fat, and perforator vessels from the abdomen to a recipient artery and vein in the chest to create a viable breast mound. post-operatively, the abdominal donor site is routinely monitored for wound dehiscence, which has a reported incidence of up to 39% in this patient population; however, this incidence typically varies from 3.5% to 14%. at the investigators' academic institution, patients who undergo diep breast reconstruction typically have cinpt or traditional tape dressings applied to the closed abdominal donor site. these dressings are selected according to surgeon preference and typically remain in-situ until hospital discharge. as there remains clinical equipoise regarding the ability of cinpt to reduce abdominal wound dehiscence, further research in the form of a parallel, two-arm rct is warranted. the investigators propose a randomized controlled superiority trial with the primary objective of comparing the incidence of wound dehiscence at 1 month in patients undergoing autologous diep breast reconstruction with cinpt versus standard tape dressings for the abdominal donor site incision. the design and conduct of the proposed study will mirror the methodology of the recently completed pilot trial (nct04985552) including randomization, interventions, and clinical outcomes. the secondary objective of this study is to evaluate other clinical outcomes comparing cinpt to standard tape dressings applied to the abdominal donor site incision. secondary clinical outcomes will include: 2) the incidence of seroma formation and surgical site infection at 1 month; 2) quality of life as measured by breast-q physical well-being abdomen and eq-5d-5l pre-operatively, 1-month, 3-months, and 6-months postoperatively; 3) scar appearance as measured by the scar-q at 1-month, 3-months, and 6-months postoperatively. as an adjunct to the main study, another secondary clinical outcome will include the overall incidence of mins as diagnosed by postoperative abnormally elevated troponin levels (as per site-specific laboratory assay thresholds) and electrocardiograms (ecg) at 6-12 hours and 1, 2, and 3 days after surgery.


Eligibility criteria:
inclusion criteria: * adult female patients (≥ 18 years old) * consent to elective immediate (i.e. performed at the time of mastectomy) or delayed (i.e. performed following mastectomy) breast reconstruction using the diep flap exclusion criteria: * patients who are pregnant * have a documented/reported allergy to adhesive dressings * body mass index (bmi) ≥ 40 kg/m2
physical fitness, body composition and frailty in elderly people.exercise program effecsts. exernet elder 3.0

Conditions: Frail Elderly Syndrome; Sarcopenia; Physical Activity

Summary: one of the major changes occurring in developed societies is a significant ageing of the population. nowadays, because of an enhanced life expectancy, 17% of the spanish population is composed of people over 65 and the number is expected to rise to 33% in 2050. aging is characterized by a gradual lifelong accumulation of molecular and cellular damage that results in a progressive and generalized impairment in several bodily functions, an increased vulnerability to environmental challenges and a growing risk of disease and risk of death. these facts led to an increase on the prevalence of diseases such as osteoporosis diabetes, sarcopenia, obesity or frailty. however, lifestyles such as physical activity could attenuated aging process, maintaining the autonomy of elders, and it has been demonstrated that even implying guided exercise programs could reverse this condition of frailty and dependence. in this way, the main aims of this research project are to analyze the effect of a multicomponent exercise program in frailty and pre-frailty people above 65 years and without cognitive impairment. thus, it is going to be evaluated at the beginning and the end of the study; body composition, physical fitness, blood parameters including vitamin d and other health related parameters included in a questionnaire. secondly, to study the perdurability of training-related gains over time.

the training will consist in a multicomponent exercise program, 3 days a week (monday, wednesday and friday). it will take place during morning in groups of 10-14 and trainers will be qualified. alll the exercise will be adapted for different levels of frailty and for their functional capacity.

Eligibility criteria:
inclusion criteria: * above 65 years * frailty of pre-frailty by sppb. exclusion criteria: * severe cognitive impairment

Keywords: elderly multicomponent exercise body composition vitamin d fitness
a phase 2a study to evaluate vmb-100 in females with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the study drug vmb-100 is an mrna encoding for igf-1. it is administered by injection into the urethra sphincter, and taken up by the muscle cells. the igf-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).

versameb ag (sponsor) is developing vmb-100 for the treatment of stress urinary incontinence (sui), and mixed urinary incontinence (mui) with a predominant stress component, a common and debilitating condition that significantly impacts quality of life, and for which there are currently no approved pharmacological therapies available in the us. the drug substance of vmb-100 is a mrna encoding human insulin-like growth factor-1 (igf-1). vmb-100 is administered as a transurethral injection into the urinary sphincter muscle. the injected mrna is taken up by the muscle tissue cells and serves as a template for the translation of the protein igf-1. insulin-like growth factor-1 is secreted into the extracellular space, where it acts to promote muscle regeneration of the urinary sphincter via auto- and paracrine activation of downstream pathways in a localized manner. the current understanding in urology is that reduced maximum urethral closure pressure (mucp) is the factor most strongly associated with sui. this implies that improving function of the closure muscles would have therapeutic merit in both sui as well as mui with a predominant stress component. no treatment which restores the physiology (regenerates the urinary sphincter muscle) is currently available. given igf-1's role in regenerating/maintaining muscle tissue women with sui may benefit from a localized increase in igf-1 levels in the urinary sphincter to regenerate muscle and restore sphincter function, thus alleviating the incontinence.

Eligibility criteria:
main inclusion criteria: * pre- or peri-menopausal female subject between 18 and 55 years of age * body mass index (bmi) of 19 to 35 kg/m2 * active sui of moderate severity for at least 6 consecutive months documented in medical history * refractory to standard of care measures * must not be pregnant, lactating, or actively trying to become pregnant. main exclusion criteria: * any concurrent condition or any clinically significant abnormality at screening which in the opinion of the investigator may affect the interpretation of safety or efficacy data or which otherwise contradicts participation in a clinical study with vmb-100 * unwilling to undergo transvaginal sonography or cystoscopy * urodynamic detrusor overactivity * history of urinary urge incontinence of neurogenic etiology. * history of or planning for pelvic radiation. * history of use of any bulking agent or botox to treat sui in the past 12 month. * history of urethral sling, anterior prolapse repair, and/or other sui procedures or surgical procedures affecting continence. * taking any medications that are known to have an effect on urinary continence or medications that may exacerbate incontinence
immediate dental implant placed in the presence of chronic inflammatory periapical lesions

Conditions: Immediate Dental Implant; Tooth Exratction; Periapical; Infection

Summary: compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal. some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates

12 implants will be immediately placed in sockets associated with chronic periapical granuloma. clinical (wound healing, pain, swelling, implant stability) and radiographic parameters (peri-implant radiolucency) will be evaluated

Eligibility criteria:
inclusion criteria: * adult patients ranging from 18 to 45 years with no gender predilection agreed to come for minimum follow-up visits for 6 months. * adequate bone beyond teeth apices without jeopardizing any anatomical structure. * single rooted mandibular teeth with chronic inflammatory periapical lesions represented as periapical radiolucency, pulp necrosis, sinus tract, failed rct. exclusion criteria: * smokers and alcoholics. * medically compromised patients having uncontrolled diabetes or coagulation disorders. * restorable teeth. * periodontitis.
neuropsychological development and functional outcome sin children with hirschsprung disease at school age

Conditions: Hirschsprung's Disease (HD)

Summary: hirschsprung's disease (hd) is a rare congenital disease (1:5000) characterized by neonatal functional low bowel obstruction that is caused by aganglionosis of the distal bowel. hd treatment consists in surgery of colonic reduction in the early childhood, requiring afterward a long-term follow-up. in the long term complications (incontinence, constipation, enterocolitis, soiling)but also iterative anesthesia in childhood and repeated hospitalizations can have negative effects on child's development. the main aim of the study is to estimate neuropsychological development at school age (6-10 years). of children operated of hd secondary aims are evaluation of the neuro-driving development and global health, comparison of quality of life levels to those of french population standards as well as to study the complex relations between on one hand the quality of life of these children and on the other hand the socio-demographic data, the initial clinical elements and the surgical coverage, as well as their health and current cognitive profile. this multicenter study included pediatric surgery departments of marseille. all children born between 1/1/2005 and 31/12/2010 and presenting hd represent the population. all the families will be contacted resting on the networks of set up follow-up. a written agreement will be collected with the parents. for all the participating children, a consultation will be organized: quality of life data (reported by children and by their parents in validated standardized questionnaires), clinical examination of the child, cognitive profile of the child. the duration of inclusion is scheduled for 12 months. this is the first french study using auto-reported data on children's quality of life at school age affected by a hd. the results of this study will allow developing hypotheses on predictive risk factors for neuropsychological development disorders. besides a better knowledge of the relation existing between these children quality of life and their functional results due to the disease could help clinicians in their medical reflections.


Eligibility criteria:
inclusion criteria: * child aged 8 to 13 * child with hirschsprung's disease (diagnosis confirmed by anatomopathological analysis), * child with no severe cerebral palsy * child with no developmental psychosis * child not showing amblyopia * child not deaf hearing * child able to answer a questionnaire in french language, * a child whose parents or legal representatives have accepted the principle of participation in this study, and who have signed an informed consent, exclusion criteria: * child deceased between birth and the date of assessment, * child with cerebral palsy * child whose parents or legal representatives refused to allow their child to participate in this study
the predictive scores for gastric cancer in gastric intestinal metaplasia (gim) patient: a recommendation for thai population

Conditions: Gastric Intestinal Metaplasia

Summary: the predictive scores for gastric cancer in gastric intestinal metaplasia(gim) patient: a recommendation for thai population. objective: to evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(gim) patient in order to propose the appropriate recommendation for thai people. research design: single center, retrospective-cohort study.

study population and sample size at faculty of medicine, chulalongkorn university the patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. estimate sample size =280 * investigational product, dosage \& route of administration * questionnaire for explore the risk factors * egd with biopsy * blood sampling for gastro panel * duration of participation * 5 years or until diagnose gastric cancer statistical method: unconditional-binary-logistic regression

Eligibility criteria:
inclusion criteria: 1. all patients were diagnosed gim 2. all patients have to sign the consent form exclusion criteria: 1. previous gastric surgery including gastrectomy and bypass surgery 2. bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants 3. hiv infection 4. history of proton pump inhibitor use within 1 week 5. history of antibiotic use within 4 weeks

Keywords: gastric intestinal metaplasia
the predictive and diagnostic value of cystatin c and high sensitive troponin

Conditions: Acute Coronary Syndrome; Chronic Kidney Diseases

Summary: our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. estimated gfr (cisgfr) with cystatin and estimated gfr (creagfr) with creatinine will be calculated. symptoms, ecg and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome

our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. estimated gfr (cisgfr) with cystatin and estimated gfr (creagfr) with creatinine will be calculated. symptoms, ecg and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome and the final diagnosis of ami will be adjudicated by 2 independent cardiologists.serial troponin measurements and egfr values will be proportioned. these values the will be evaluated and compared for patients with acute coronary syndrome(culprit lesion on conventional coronary angiography) and non-acs ones . with these data we aim to facilitate the diagnosis of acute coronary syndrome,increase the specificity and sensitivity of cardiac troponins for the diagnosis of acute coronary syndrome of patients with chronic kidney disease, increase the utility of high sensitive troponins for patients with chronic kidney disease. again, with these data, it is aimed to reduce the number of false negative and false positive diagnosis of acute coronary syndrome .

Eligibility criteria:
inclusion criteria: 1. age over 18, 2. chronic kidney diease having chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting) - exclusion criteria: 1. stemi, 2. age less than 18, 3. missing data, 4. patients referred to or accepted from another medical facility
a check-list including lung ultrasound for ed patients with arf

Conditions: Acute Respiratory Failure

Summary: the aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room. adult patients admitted to the emergency room for acute respiratory failure will be offered the study. the emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis. a diagnostic hypothesis will be made after completion of the checklist. the emergency physician can perform additional examinations and treatment after completion of the checklist. the final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization. the main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.


Eligibility criteria:
inclusion criteria: * patient with acute respiratory failure table (spo2 90% in ambient air or need more than 3 l/min of oxygen to have spo2 \> 92% and/or signs of respiratory struggle sign and/or respiratory rate control \> 25 cycles/minute and/or cyanosis) * over 18 years old exclusion criteria: * pregnant, parturising or breastfeeding women * patient who has already participated in the study in the previous 7 days

Keywords: covid19 acute respiratory failure ultrasound checklist emergency diagnosis
pharmacokinetic drug interaction between teneligliptin and empagliflozin

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.


Eligibility criteria:
inclusion criteria: * healthy adults between 19 and 45 years of age (both inclusive) at the screening visit * body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit * subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions exclusion criteria: * history of type 1 diabetes mellitus and/or diabetic ketoacidosis * severe infection, surgery, or severe trauma within 6 months prior to the screening visit * hereditary problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption * treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit * any laboratory test or 12-lead ecg finding based on which the subject is determined ineligible to participate in the study * subject determined by the principal investigator to be ineligible for study conduct for other reasons
physical activity and disability prevention in postmenopausal women

Conditions: Metabolic Syndrome; Fall Risk; Sarcopenia in Elderly; Osteopenia, Osteoporosis; Cardiovascular Diseases; Dementia; Quality of Life Outcomes; Cognitive Ability, General

Summary: the aim of this clinical study is to examine the impact of physical activity on the physical and mental health of postmenopausal women, with a particular focus on the development of disability. the main questions this study aims to answer are: 1. can physical activity programs (nordic walking, bungy pump, strength training, functional general conditioning training) prevent loss of mobility, bone density and urinary incontinence, reduce the risk of falls, lower metabolic syndrome parameters, and improve cardiovascular endurance in postmenopausal women? 2. do regular exercises improve cognitive functions, motivation, memory, visual coordination, mood, and quality of life in postmenopausal women? researchers will compare the test groups (nordic walking, bungy pump, strength training, functional general conditioning training) with the control group to determine whether physical activity brings benefits in terms of physical and mental health compared to no intervention. participants will: take part in a three-month physical activity program that includes nordic walking, bungy pump exercises, functional general conditioning training and strength training, depending on the group. the control group will not participate in any additional physical exercise program and will continue with their usual daily activities.

this study will involve two testing phases (pre- and post-training). prior to the first test, participants' physical activity will be measured over a period of seven days using polar accelerometers to evaluate the relationship between their daily physical activity and health. each testing phase will last two days; on the first day, blood samples will be collected, and preliminary analyses of body composition and dietary records will be conducted. on the second day, physical fitness tests and psychological test swill be performed at the awfis sports exercise laboratory in gdańsk. biological materials (serum) will be frozen and subsequently tested by contractors at the awfis sports genetics laboratory. participants will be required to maintain a dietary diary to record their dietary intake for the three days preceding the tests.

Eligibility criteria:
inclusion criteria: * postmenopausal women over 60 years old (i.e. more than 12 months since their last menstrual cycle). there were no contraindications to exercise after case reports and initial diagnosis. informed consent must be signed, agreeing to participate in research and physical exercise programs. exclusion criteria: * uncontrolled high blood pressure. rheumatoid arthritis. type 2 diabetes. are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks. unwillingness to stick to a prescribed schedule.

Keywords: physical activity aerobic capacity mobility cognitive functions quality of life disability postmenopausal women physical fitness
direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care

Conditions: Lip and Oral Cavity Squamous Cell Carcinoma; Oral Cavity Verrucous Carcinoma; Stage 0 Lip and Oral Cavity Cancer; Tongue Cancer

Summary: this clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.

primary objectives: i. to assess the diagnostic benefit of the velscope (direct visual fluorescence) inspection in oral examination. ii. efficacy of the velscope in identifying dysplastic (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes. iii. accuracy of clinical judgment versus velscope findings. iv. ability of the velscope to identify lesions or extent of lesions beyond what is clinically apparent. outline: patients undergo conventional oral examination (coe) followed by direct visual fluorescence examination (dvfe). patients with tissue abnormalities found by coe or dvfe undergo scalpel biopsy within 2 weeks.

Eligibility criteria:
inclusion criteria: * high-risk population: * 33 consecutive consenting patients presenting to the ohio state university james cancer hospital otolaryngology department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (cis), or squamous cell carcinoma (scc) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate * general population: * 250 consecutive consenting patients presenting to the ohio state university college of dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate

Keywords: direct visual fluorescense oral examination oral cancer